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Adalimumab Shows Promise for Refractory Psoriatic Arthritis


 

NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.

“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”

Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.

All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.

At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.

Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.

This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.

Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.

Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).

Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.

The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.

Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.

Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.

All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.

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